Nit-Occlud® PFO


The nitinol occluder system Nit-Occlud® PFO was specially developed to close congenital PFO heart defects (patent foramen ovale, or persistent foramen ovale). Nit-Occlud® PFO is knitted from a single Nitinol wire, making protruding fixation-clamps obsolete. Nit-Occlud® PFO`s unique single-layer distal disc, reduces the metal used in the left-atrium (LA) by 50%, decreasing the thrombo-embolic risk.


Benefits

Special design  The occluder consists of a single nitinol wire with a double-layer right atrial disc and a single-layer left atrial disc. By the minimal amount of Nitinol in the LA, the thrombo-embolic risk is being reduced.

Patented single-wire knit  Thanks to the single-wire design, there is no need for the protruding clasps which are usually used. This makes for a very low profile.

Various sizes  The Nit-Occlud® PFO is available in sizes of 20 mm, 26 mm and 30 mm.

Easy to use  The easy-to-use application system was developed specifically for Nit-Occlud® PFO procedures.

Soft atraumatic rim

Details

  • Single wire-knit double umbrella
  • No need for protruding clamps to fixe loose wire ends
  • Single-layer left atrial disc in a concave shape
  • Diameter of the left atrial disc identical with right atrial disc
  • Easy release system
  • Repositioning possible at any time prior to release
  • Unstressed release of also possible at largest angle
  • Pre-mounted 9 F and 10 F systems
  • Radiopaque
  • MR compatible

Tech. Data

  • Woven Nitinol shield with two Dacron membranes
  • 120 cm catheter

Practice

Field of structural heart defects; for treating PFO (patent foramen ovale).

The Nit-Occlud® PFO shield is a permanent implant used for closing PFOs. It is inserted in the PFO using minimally invasive catheter technology. The shield consists of Nitinol, a shape memory material, which resembles a double shield in its relaxed state.

Dacron, a synthetic material, is incorporated in the right atrial double disc to achieve a high acute closure rate. The left atrial disc is a single disc in order to accelerate the endothelialisation process. Nit-Occlud® PFO shields are available in various sizes to enable a wide range of PFOs to be treated with the best possible results.

The Nit-Occlud® PFO shield system consists of two main components: the shield and a delivery system including a single applicator.

Handling

Diagnostic Measurements

As a first step, a full transesophageal echocardiographic study must be carried out. If possible, all intracardiac findings which are necessary for the procedure should be included in the study.

Selection of the Nit-Occlud® PFO Umbrella

Selection of the umbrella will depend on the distance between the PFO and the aortic root or between the PFO and the junction of the superior vena cava, as measured in the transesophageal echocardiogram (cf. Tab.: Selection of the Nit-Occlud® PFO umbrella and the recommended Mullins sheath).

A 45° curved 9 F Mullins sheath is recommended for the PFO 20 and 26 umbrella systems, and a 45° curved 10 F Mullins sheath for the PFO 30 umbrella system.

Diameter election of the Nit-Occlud® PFO umbrella
Occluder TypePFO-20, REF 182020PFO-26, REF 182026PFO-30, REF 182030
20 mm26 mm30 mm
Distance aortic root-PFO≥11 mm, <14 mm≥14 mm, <16 mm≥16 mm
Distance superior vena cava-PFO≥11 mm, <14 mm≥14 mm, <16 mm≥16 mm
Recommended Mullins sheath45° curved 9FF

45° curved 9F

45° curved 10F

Auxiliary Imaging Procedures

Closure of the PFO is performed in the cardiac catheterisation laboratory under transesophageal echochardiography and x-ray fluoroscopy.

Application Range

Indication:

Primary Indication:

Interventional closure of a diagnostically ascertained patent foramen ovale (PFO) after a neurological event, e.g. transient ischemic attack or stroke.

Relative Indication:

Recent studies show that in some cases of frequent migraine attacks, severity and frequency could be decreased by PFO closure.
Furthermore, recent studies show that in divers with patent foramen ovale, decompression sickness with unknown origin could be decreased by PFO closure. Therefore, in these few cases there is a relative indication for occlusion of a known patent foramen ovale incase of decompression sickness or migraine.

Contraindication:

Pathological or physical conditions that exclude the implantation of a Nit-Occlud® PFO umbrella:

  • Active endocarditis, or active infection at the time of the implantation
  • Anatomical or physiological structures that do not permit transesophageal echocardiography
  • Atrial fibrillation or atrial flutter
  • Closure of other structural cardiac defects than a patent foramen ovale
  • Concomitant cardiac anomalies requiring an operative procedure
  • Hemorrhagic diseases (coagulopathy, tendency to haemolysis)
  • Hypersensitivity to contrast medium or nickel
  • Potential physical influence on intracardiac or intravascular structures from the occluder
  • Recent myocardial infarction
  • The required sheaths cannot be passed through the relevant vessels for access to the PFO
  • Thrombus in a vessel through which access to the PFO is made
  • Thrombus in the vicinity of the implantation site

Manufacturer

pfm medical mepro gmbh

Am Söterberg 4

66620 Nonnweiler-Otzenhausen, Germany

Ordering Information

Nit-Occlud® PFO
REFDiameterImplantation catheterImplantation catheter lengthPU
18202020 mm9 Fmax. 90 cm1
18202626 mm9 Fmax. 90 cm1
18203030 mm10 Fmax. 90 cm1

Video